MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LIGHTTRAIL SINGLE USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M006864640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplement report will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a lighttrail 270um single use laser fiber was opened for use in a flexible ureteroscopy procedure in the kidney performed on (b)(6) 2018.According to the complainant, during preparation, the laser body broke upon removal from the package.Reportedly, there was no damage noted to the package or device prior to opening the product pouch.The procedure was completed with another laser fiber.There were no adverse patient effects reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on november 16, 2018 that a lighttrail 270um single use laser fiber was opened for use in a flexible ureteroscopy procedure in the kidney performed on (b)(6) 2018.According to the complainant, during preparation, the laser body broke upon removal from the package.Reportedly, there was no damage noted to the package or device prior to opening the product pouch.The procedure was completed with another laser fiber.There were no adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Problem code 1069 captures the reportable event of fiber broke.A lighttrail single use laser fiber was returned broken.The fiber measured approximately 201.1 cm from the top of the connector to the break.The remainder of the fiber, including the distal tip, was not returned.Review and analysis of all available information indicated that the damage to the device is likely a result of handling.Therefore the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and no deviations were found.

• Brand Name: LIGHTTRAIL SINGLE USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; model farm road,; marlborough MA 01752
• MDR Report Key: 8156292
• Report Number: 3005099803-2018-61900
• Device Sequence Number: 16685712
• Product Code: GEX
• UDI-Device Identifier: 08714729894995
• UDI-Public: 08714729894995
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2022
• Device Model Number: M006864640
• Device Catalogue Number: 6464
• Device Lot Number: 0201708165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1